Kornimate/medical-research-clean huggingface dataset:
a study of selpercatinib after surgery or radiation in participants with non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (nsclc), who have already had surgery or radiation. participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. participation could last up to three years.


Eligibility criteria:
inclusion criteria: * must have histologically confirmed stage ib, ii, or iiia nsclc. * must have an activating ret gene fusion in tumor based on polymerase chain reaction (pcr), next generation sequencing (ngs), or another molecular test per sponsor's approval. * must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for stage ib, ii, or iiia nsclc. -- must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion. * maximum time allowed between definitive therapy completion and randomization must be: * 10 weeks if no chemotherapy was administered * 26 weeks if adjuvant chemotherapy was administered * eastern cooperative oncology group (ecog) performance status of 0-1. * adequate hematologic, hepatic, and renal function. * willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of the study and for at least 2 weeks after last dose of study drug. exclusion criteria: * additional oncogenic drivers in nsclc, if known. * evidence of small cell lung cancer. * clinical or radiologic evidence of disease recurrence or progression following definitive therapy. * known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids. * clinically significant active cardiovascular disease or history of myocardial infarction within six months prior to planned start of selpercatinib or prolongation of the qt interval corrected for heart rate using fridericia's formula (qtcf) greater than 470 milliseconds. * have known uncontrolled human immunodeficiency virus (hiv)-1/2 infection. * have known active hepatitis b or c. * active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. * major surgery within 4 weeks prior to planned start of selpercatinib. * clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug. * other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed greater than or equal to two years previously and not currently active. * pregnancy or lactation. * prior treatment with a selective ret inhibitor (e.g. selpercatinib or pralsetinib).
glucocorticoid on the prognosis of tevar

Conditions: Aortic Dissection

Summary: to explore the potential prognostic effect of glucocorticoid on the postoperative aorta-related adverse events after aortic dissections patients underwent thoracic endovascular aortic repair (tevar), glucocorticoid (30mg/kg) will be intravenously given within 2h after tevar.

this is a prospective, open, single-center, randomized controlled trial. number of patients: 240 patients will be included and undertaken tevar.about 120 patients will be given glucocorticoid within 2h after tevar as experimental group, and the other 120 patients will be given saline as control group. follow-up: 1. aortic computed tomographic angiography (cta) examination 6, 12 and 24 months after tevar; 2. telephone or clinical follow-up at 1, 2, 3, 6, 12 and 24 months. primary outcome measure: aorta-related adverse events. second outcome measure: 30-day mortality after tevar, success rate of endovascular repair, drug-related adverse events.

Eligibility criteria:
inclusion criteria: 1. age from 18 to 80, male or unpregnant female; 2. diagnosed as aortic dissection, excluding intramural hematoma and penetrating aortic ulcer; 3. complicated aortic dissection with definite indications of tevar; 4. voluntarily signed the informed consent form; 5. good compliance with the instructions and cooperate with follow-up. exclusion criteria: 1. no appropriate vessel approaches; 2. patients with connective tissue diseases (such as marfan syndrome); 3. patients with endocrine disease,such as diabetes mellitus, or undergoing hormonotherapy; 4. bad compliance with the instructions and follow-up; 5. allergic to nitinol and contrast medium; 6. estimated life expectancy is less than 24 months.
cardiopulmonary and metabolic responses to early exercise in patients after coronary arterial bypass grafting

Conditions: Acute Myocardial Infarction: Rehabilitation Phase; Coronary Artery Bypass Graft Triple Vessel; Physical Activity

Summary: coronary arterial bypass graft surgery (cabg) is proven safe with improved survival and greater quality of life in patients with coronary arterial disease. evidences on the cardiovascular and gas-exchanges responses during and right after early exercise-based rehabilitation of this patients are limited. objective: the investigators aim to analyse breath-by-breath cardiopulmonary and metabolic responses during six-minute walk test (6mwt) and shuttle walk test (swt) in patients with or without left ventricular dysfunction (lvd) after cabg. in addition, the investigators will investigate oxygen consumption and cardiopulmonary responses during the early exercise-based rehabilitation in the first days after surgery. methods: according to the left ventricular ejection fraction (lvef), subjects will be allocated into two groups: with lvd (lvef \ 45%). patients will be submitted to the 6mwt and swt linked to portable spirometric-telemetric device before and 6 days after cabg. during the first days after surgery, patients will be evaluated about pulmonary function and respiratory strenght at rest and oxygen consumption during the portable cycle ergometer protocol. clinical outcomes as time to hospital discharge, pulmonary complications and occurence of arrythmias will be assessed during inpatient time until hospital discharge. incidence of mortality, hospital readmission and angina recurrence will be evaluated in a one-year follow up.


Eligibility criteria:
inclusion criteria: * age between 35 to 75 years old; * coronary arterial disease proved by coronary angiography * elective coronary arterial bypass grafting exclusion criteria: * pulmonary chronic disease * disabling neurological or orthopedic disease * morbidity obesity * urgency surgery * bilateral pleural opening * arrhythmias during exercise protocol * prolonged mechanical ventilation (\>12 hours) * inability to comprehend or perform the tests
dose confirmation and dose expansion phase 1 study of io-108 and io-108 + anti-pd-1 in solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a phase 1 study to evaluate the safety, tolerability, pk, and preliminary efficacy of io-108 monotherapy and in combination with anti-pd-1 monoclonal antibody pembrolizumab or tislelizumab in adult patients with advanced solid tumors. the study will be conducted in 3 parts, including part a io-108 monotherapy dose confirmation; part b io-108 + anti-pd-1 dose confirmation, and part c dose expansion.


Eligibility criteria:
inclusion criteria: 1. age ≥18, and \< 75. 2. part a and part b cohort 1: patients must have histologically or cytologically confirmed advanced or metastatic solid tumor and have failed, or have been intolerant for standard systemic therapy, or for whom no treatment known to confer clinical benefit exists. part b cohort 2 and part c: patient with advanced or metastatic solid tumor who meet the specific criteria. 3. patients have at least 1 measurable disease per recist v1.1 as assessed by local clinical site. 4. eastern cooperative oncology group (ecog) performance status 0 to 1. 5. patients must have adequate hematologic function, hepatic function and renal function. exclusion criteria: 1. patients who previously received a monoclonal antibody therapy targeting lilrb2/ilt4 (including io-108). 2. patients who received chemotherapy, radiotherapy, biologic therapy, targeted therapy, immunotherapy, or other investigational anti-cancer therapy \< 4 weeks prior to their first day of study drug administration. 3. requires systemic corticosteroids at a dose of \>10 mg daily of prednisone or the dose equivalent to other systemic corticosteroid, or other immunosuppressive agents ≤ 14 days prior to the first dose. 4. history of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease expect for radioactive pulmonary fibrosis not requiring corticosteroid treatment. 5. symptomatic central nervous system (cns) metastases. note: other protocol defined inclusion/exclusion criteria may apply.
modulation of the immune response in patients with pancreatic tubular adenocarcinoma

Conditions: Pancreatic Tubular Adenocarcinoma

Summary: interventional study of modulation of immune response in patients with pancreatic tubular adenocarcinoma after resection and gemcitabine treatment. when included, patients are pre-treated with moderate doses of cyclophosphamide. then infusions of allogeneic mononuclear cells are given.


Eligibility criteria:
inclusion criteria: * ecog performance status 0-2 at the time of inclusion * following r0 or r1 pancreatic tubular adenocarcinoma resection and adjuvant gemcitabine treatment exclusion criteria: * pregnancy * less than 3 mths expected survival * serious comorbidity * age above 70 yrs

Keywords: pancreatic tubular adenocarcinoma adjuvant setting
dose escalation of bcx10013 in participants with paroxysmal nocturnal hemoglobinuria (pnh)

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: this is a multicenter, open-label, intra-subject, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and therapeutic potential of bcx10013 in participants with pnh. approximately 8 participants will be enrolled in this study. participants may receive treatment for up to 52 weeks.


Eligibility criteria:
key inclusion criteria: 1. male or non-pregnant, non-lactating female adults ≥ 18 years old. 2. documented diagnosis of pnh confirmed by flow cytometry. 3. body mass index (bmi) ≤ 40 kg/m\^2. 4. are either: (a) naïve to treatment with a complement inhibitor; or (b) have received no treatment with ravulizumab for at least 12 months prior to the screening visit and have received no treatment with eculizumab or pegcetacoplan for 6 months prior to the screening visit. 5. documentation of current vaccinations against n. meningitidis, s. pneumoniae, and h. influenzae type b \[hib\] or willingness to start vaccination series at least 14 days prior to day 1. key exclusion criteria: 1. known history of or existing diagnosis of hereditary complement deficiency. 2. history of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation during the study. 3. myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition, including unstable angina, severe congestive heart failure, unexplained syncope, arrhythmia, and critical aortic stenosis. 4. history of malignancy within 5 years prior to the screening visit. 5. treatment with anti-thymocyte globulin within 180 days prior to the screening visit. 6. initiation of treatment with an erythropoiesis-stimulating agent (eg, erythropoietin), a thrombopoietin receptor agonist (eg, eltrombopag), or danazol within 28 days prior to the screening visit. 7. receiving iron with an unstable dose (ie, increasing or decreasing) in the 28 days prior to the screening visit.

Keywords: paroxysmal nocturnal hemoglobinuria factor d complement inhibitor alternative pathway inhibitor biocryst
consistency of electrical cardiometry and pulmonary artery catheter

Conditions: Pulmonary Arterial Hypertension; Right Ventricular Dysfunction

Summary: currently, the gold standard method to estimate co in patients with pah or rv dysfunction is pulmonary artery catheter (pac), however, the invasiveness and complexity of pac has limited its usefulness in many clinical scenarios. by measuring the thoracic electrical bioimpedance, electrical cardiometry (ec) technique has been reported to noninvasively estimate cardiac output (co) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. however, in patients with pulmonary arterial hypertension (pah) and/or right ventricular (rv) dysfunction, few study has been reported. the aim of this study is to evaluate the agreement between co measured by pac as the referenced method and co measured by ec technique in patients with pah and/or rv dysfunction.


Eligibility criteria:
inclusion criteria: * adult cardiac surgery patients * pulmonary artery hypertension and/or right heart dysfunction * mechanical ventilation exclusion criteria: * life threatening arrhythmia * severe valve regurgitation * left ventricular ejection fraction less than 30% * patients with mechanical circulatory support
a trial to assess consumer self-selection and use of gabapentin for occasional sleeplessness in an over-the-counter environment

Conditions: Transient Insomnia

Summary: the purpose of this study is to assess consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (otc) product label.


Eligibility criteria:
inclusion criteria: * age of 18 years or older with symptoms of sleeplessness * provided informed consent exclusion criteria: * contraindications to use of gabapentin
vancomycin dosage adjustment for mrsa infections

Conditions: Methicillin-Resistant Staphylococcus Aureus

Summary: an open-label randomized controlled trial to compare two vancomycin dosage adjustment methods

an open-label randomized controlled trial to compare two vancomycin dosage adjustment methods; a vancomycin trough concentration method and a equation-based method.

Eligibility criteria:
inclusion criteria: 1. thai hospitalized patients, age\>18 years 2. require vancomycin therapy ≥ 3 days 3. documented mrsa infection including pneumonia, bacteremia, intra-abdominal infection or skin and soft tissue infection 4. have been checked for serum creatinine within 48 hours and serum albumin within 7 days prior to enrollment 5. received an appropriate loading dose of vancomycin 6. have been treated with an appropriate maintenance dose of vancomycin 7. willing to sign an informed consent exclusion criteria: 1. crcl\< 10 ml/min or receiving renal replacement therapy 2. pregnancy or lactation 3. actual bw\> 90 kg 4. serum albumin \<2 g/dl 5. having an active cancer or receiving chemotherapy 6. hx of vancomycin allergy

Keywords: methicillin-resistant staphylococcus aureus vancomycin
evaluation and comparison of noninvasive blood glucose concentrations

Conditions: Insulin Dependent Diabetes; Non Insulin Dependent Diabetes; Gestational Diabetes

Summary: comparison of noninvasive glucose measurement performance versus standard invasive reference measurements.

the objectives of this study are * collect subject data on a near-infrared spectroscopy-based glucose meter * evaluate existing instrumentation, calibration algorithms and calibration maintenance techniques * collect data on the physiological and environmental sources of interference and degradation of measurement accuracy.

Eligibility criteria:
inclusion criteria: * female aged ≥ 18 and ≤ 50 years of age at time of enrollment * females with self reported diagnosis of type i, type ii or gestational diabetes, or no self reported diagnosis of diabetes. exclusion criteria: * severe heart disease as evidenced by peripheral edema (self reported) * currently taking lasix (self reported) * liver disease as evidenced by jaundice (self reported) * receiving dialysis or having known renal compromise (self reported) * skin damage at optical sampling site * scars, tattoos, rashes or other disruption/discoloration on the right index finger * recent (within past month) or current oral steroid therapy or topical steroids applied to the hands; inhaled steroid therapy (self reported) * current chemotherapy, or chemotherapy within the past 12 months (self reported)

Keywords: diabetes gestational diabetes female
coronavirus (covid-19) acei/arb investigation

Conditions: Hypertension; COVID-19

Summary: coronavirus disease 2019 (covid-19) is a pandemic infection caused by a virus called severe acute respiratory syndrome coronavirus 2 (sars-cov-2). because sars-cov-2 is known to require the angiotensin-converting enzyme 2 (ace-2) receptor for uptake into the human body, there have been questions about whether medications that upregulate ace-2 receptors might increase the risk of infection and subsequent complications. one such group of medications are anti-hypertensives that block the renin-angiotensin system, including both angiotensin converting enzyme inhibitors (acei) and angiotensin ii receptor blockers (arb). both acei and arb are widely used for the treatment of hypertension. early reports from china and italy suggest that many of those who die from covid-19 have a coexisting history of hypertension. consequently, there have been questions raised as to whether these 2 types of blood pressure medication might increase the risk of death among patients with covid-19. however, it is well known that the prevalence of hypertension increases linearly with age. therefore, it is possible that the high prevalence of hypertension and acei/arb use among persons who die from covid-19 is simply confounded by age (older people are at risk of both a history of hypertension and dying from covid-19). whether these commonly prescribed blood pressure medications increase the risk of covid-19 or not remains unanswered. statements from professional cardiology societies on both sides of the atlantic have called for urgent research into this question. our study aims to randomize patients with primary (essential) hypertension who are already taking acei/arb to either switch to an alternative bp medication or continue with the acei/arb that they have already been prescribed. adults with compelling indications for acei/arb will not be enrolled.


Eligibility criteria:
inclusion criteria: * men and non-pregnant women aged 60 or over * known diagnosis of hypertension * current use of acei or arb for the treatment of hypertension * covid-19 naïve (i.e. not known to be infected) * english speaker exclusion criteria: * known diabetic nephropathy * known heart failure with reduced ejection fraction * resistant hypertension (defined as blood pressure that remains above goal despite concurrent use of three anti-hypertensive agents of different classes, one of which should be a diuretic, or as blood pressure that is controlled with four or more medications) * contraindications or allergies to ccb or thiazide * unconscious patients * current psychiatric in-patients * patients in an emergency medical setting * inability to consent

Keywords: hypertension blood pressure covid-19 coronavirus disease 2019 novel coronavirus coronavirus cardiovascular diseases pandemic critical care intubation noninvasive ventilation angiotensin converting enzyme angiotensin converting enzyme 2 renin-angiotensin system antihypertensive agents angiotensin-converting enzyme inhibitors angiotensin receptor antagonists calcium channel blockers diuretics ace-2
effects of postconditioning on myocardial reperfusion

Conditions: Myocardial Reperfusion; Myocardial Infarction

Summary: the purpose of this study is to investigate the effects of postconditioning on myocardial reperfusion in patients with st-segment elevation myocardial infarction.


Eligibility criteria:
inclusion criteria general inclusion criteria * subject must be at least 18 years of age. * subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving postconditioning and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure * diagnosis of stemi 1. presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset 2. st-segment elevation more than 1 mm in at least 2 contiguous leads angiographic inclusion criteria * target lesion(s) must be located in a native coronary artery * target lesion(s) must be amenable for percutaneous coronary intervention * timi flow grade of infarct related arteries \<2 general exclusion criteria * patients with hemodynamic instability or those with cardiogenic shock * target lesion is located in left main stem * rescue pci after thrombolysis or facilitated pci * non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) * female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study

Keywords: post-conditioning st-elevation myocardial infarction angioplasty, transluminal, percutaneous coronary
nirs and doppler to predict nec in risk neonates

Conditions: Necrotizing Enterolitis

Summary: the main objective is to evaluate the interest of cerebro-splanchnic oxygenation ratio (csor) for early diagnosis of necrotizing enterocolitis (nec) in neonates with rectal bleeding and/or abdominal distension. csor will be determined using near infrared spectroscopy (nirs).


Eligibility criteria:
inclusion criteria: * less than 28 days neonates hospitalised in neonatology care unit presenting rectal bledding and/or abdominal distension * signed authorization by the parents (consent form) exclusion criteria: * - cutaneous lesions in the regions of monitoring * emergency for nec

Keywords: rectal bleeding necrotizing enterolitis splanchnic oxygenation mesenteric doppler
lcd solution versus calcipotriol cream in the treatment of moderate plaque psoriasis

Conditions: Chronic Plaque Psoriasis

Summary: the purpose of this study is to compare the safety and effectiveness of a new topical lcd solution and a commercially available calcipotriol (vitamin d) cream in reducing the symptoms of plaque psoriasis and improving the quality of life in adults.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * able and willing to provide written informed consent * diagnosed with chronic plaque psoriasis * 3% to 15% body surface area involved * in good general health exclusion criteria: * other current treatments for psoriasis * renal or liver dysfunction * pregnant or nursing

Keywords: psoriasis
lactobacillus reuteri in adult with functional chronic constipation

Conditions: Functional Constipation

Summary: a double-blind, placebo randomized controlled trial, to evaluate the effects of l. reuteri in adult patients with functional constipation.

patients affected by functional constipation according to rome iii criteria. the increase of bowel movements/week frequency was the primary outcome, while the improvement of stool consistency was the secondary outcome.

Eligibility criteria:
inclusion criteria: * functional constipation rome iii exclusion criteria: * hypothyroidism or other metabolic or renal abnormalities, or * antibiotic's treatment, * probiotic or prebiotic supplementation in the last month